(363 days)
The SomnoTraxx System is intended to augment the standard follow-up care of patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. It is intended for home use only in conjunction with ResMed S7 Elite and AutoSet Spirit CPAP Systems Positive Airway Pressure flow generators.
SomnoTraxx System is not intended to provide automated treatment decisions nor to be used as a substitute for a competent healthcare professional's judgment.
All patients' medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The S7 Elite and AutoSet Spirit CPAP Systems are indicated for the treatment of obstructive sleep apnea (OSA) in adult patients.
The S7™ Elite (K013909) and AutoSet® Spirit™ (K013843) CPAP Systems are microprocessor controlled blower-based systems that generate Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA).
The system includes the flow generator, patient tubing and a mask (patient interface). For additional humidification, several humicifiers, including the integrated HuMDARE 2i, are designed to be compatible with the flow generators. AutoScan software allows viewing of flow-generator stored treatment data via a PC, transmitting the data using a direct connection or a modem.
The SomnoTraxx™ System is designed to be used with ResMed's S7™ Elite and AutoSet Spirit™ CPAP The common raise " yetner retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and web-based access. Access to the data is limited to subscribers of the system. There is no patient access to the system.
The SomnoTraxx™ System is comprised of two distinct components, the ResTrax™ and the Server System. Data are extracted from the flow generator, transmitted via a wireless network, stored in a database, transmitted via the Internet and displayed for review by a healthcare provider. Both components must be present in order for the SomnoTraxx™ System to function.
ResTrax™ ~ResTrax™ is an optional wireless module designed to attach to a ResMed S7™ Elite or AutoSet® Spirit™ flow generator using a docking mechanism allows the device to be electrically connected via the existing 15-pin expansion port located at the rear of the flow generator. When attached, the ResTrax™ can automatically collect usage and therapeutic information stored within the flow generator's memory.
The ResTrax™ sends and receives information utilizing existing messaging networks providing wireless coverage to large portions of the US population.
Server System – The Server System consists of several functional software modules that are designed to retrieve information from flow generators through the ResTrax™ and a wireless messaging network, store the information in a database and provide a secure interface into the system allowing users (not patients) to schedule information retrieval and view the results.
The provided text describes a 510(k) submission for the S7™ Elite and AutoSet® Spirit™ CPAP Systems with the SomnoTraxx™ System. This submission is for a modification to an existing device, specifically adding an accessory (the SomnoTraxx™ System) for wireless data transmission.
However, the document is a regulatory filing that focuses on demonstrating "substantial equivalence" of the modified device to predicate devices, rather than a detailed report of a study designed to prove the device meets specific acceptance criteria in the manner one might find for a novel diagnostic or therapeutic algorithm.
Therefore, much of the requested information regarding detailed acceptance criteria tables, specific performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly provided in this type of regulatory document.
Here's what can be extracted and inferred based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the SomnoTraxx™ system's data transmission or display functionalities, nor does it present detailed quantitative performance results against such criteria. The "acceptance criteria" here refer more broadly to demonstrating that the modified device (with SomnoTraxx™) still functions safely and effectively, and is "substantially equivalent" to predicate devices.
The key statement regarding performance is:
"Design Verification and Validation were performed on the S7 Elite™ & AutoSet® Spirit™ CPAP Systems with SomnoTraxx™ System, in accordance with the risk analysis and product requirements. All tests with ourned the product meets the acceptance criteria. ResMed has determined that the modified design has oonlined the product mode effectiveness of the device."
This indicates that internal tests were conducted, and the reported device performance is that it "meets the acceptance criteria" and maintains the "effectiveness of the device" (meaning the core CPAP function is not degraded by the addition of SomnoTraxx™ and the SomnoTraxx™ itself performs as intended). No specific numerical performance metrics are given.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "Design Verification and Validation" tests but does not detail the number of units, data points, or patients used in these tests.
- Data Provenance: Not specified explicitly as patient data. The tests would likely involve laboratory or simulated environments to verify the functionality of the wireless transmission and data retrieval. As the SomnoTraxx™ is an accessory for existing CPAP systems for home use in the US, the provenance of eventual usage data would be from US patients in a home setting, but the verification and validation data for the accessory itself are not detailed. These tests are likely retrospective, as they are performed on the designed system before marketing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not specified. This type of information is typically for diagnostic algorithms where a "ground truth" needs to be established (e.g., presence or absence of a disease). For a system focused on wireless data transmission of usage and therapeutic information, the "truth" is whether the transmitted data accurately reflects the data stored in the CPAP device. This would be verified through technical tests, comparing source data to received data, rather than through expert medical assessment of cases.
4. Adjudication Method
Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts who establish a ground truth. Since expert consensus on medical findings is not the nature of the "ground truth" for this device, an adjudication method is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study assesses how human readers' performance changes with or without AI assistance. The SomnoTraxx™ system is a data transmission and display system, not an AI-assisted diagnostic or interpretive tool that directly aids human readers in making a diagnosis or interpretation in the clinical sense. It augments follow-up care by providing data, but it does not replace or assist a human in interpreting diagnostic images or complex medical signals.
6. Standalone (Algorithm Only) Performance Study
The SomnoTraxx™ system's core function (wireless transmission and display of data) is inherently "standalone" in that it performs its function without human intervention in the data transmission process itself. However, it is an "augmentation" to human follow-up care. The testing would have focused on the accuracy and reliability of the data transmission and storage, which can be considered its standalone performance. No specific performance metrics like accuracy, reliability percentages, or latency are provided in this summary.
7. Type of Ground Truth Used
For the SomnoTraxx™ system, the "ground truth" would be the actual usage and therapeutic information stored within the S7 Elite or AutoSet Spirit CPAP flow generator's memory. The verification tests would have compared the wirelessly transmitted and displayed data against this source data to ensure fidelity.
8. Sample Size for the Training Set
Not applicable. The SomnoTraxx™ system's functionality (wireless data transmission) is based on engineering design and communication protocols, not on machine learning algorithms that require a "training set" to learn from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).